CARBIDOPA-LEVODOPA- carbidopa and levodopa tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH), LEVODOPA (UNII: 46627O600J) (LEVODOPA - UNII:46627O600J)

Prieinama:

Advagen Pharma Ltd.,

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa. Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with carbidopa and levodopa tablets. These inhibitors must be discontinued at least two weeks prior to initiating therapy with carbidopa and levodopa tablets. Carbidopa and levodopa tablets

Produkto santrauka:

Carbidopa and levodopa tablets USP 10 mg/100 mg are light blue, speckled, round, uncoated tablets, debossed with “Λ46” on one side and plain on other. They are supplied as follows: NDC 72888-106-30, bottles of 30. NDC 72888-106-01, bottles of 100. NDC 72888-106-05, bottles of 500. NDC 72888-106-00, bottles of 1000. Carbidopa and levodopa tablets USP 25 mg/100 mg are light yellow, speckled, round, uncoated tablets, debossed with “Λ47” on one side and plain on other. They are supplied as follows: NDC 72888-107-30, bottles of 30. NDC 72888-107-01, bottles of 100. NDC 72888-107-05, bottles of 500. NDC 72888-107-00, bottles of 1000. Carbidopa and levodopa tablets USP 25 mg/250 mg are light blue, speckled, round, uncoated tablets, debossed with “Λ49” on one side and plain on other. They are supplied as follows: NDC 72888-108-30, bottles of 30. NDC 72888-108-01, bottles of 100. NDC 72888-108-05, bottles of 500. NDC 72888-108-00, bottles of 1000. Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store in a tightly closed container, protected from light and moisture. Dispense in a tightly closed, light-resistant container. All trademarks are the property of their respective owners. Manufactured by: Rubicon Research Private Limited Ambernath, Dist: Thane, 421506 India Distributed by: Advagen Pharma Ltd 666 Plainsboro Road Suite 605 Plainsboro, NJ 08536, US Revision: 11/21

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

CARBIDOPA-LEVODOPA- CARBIDOPA AND LEVODOPA TABLET
ADVAGEN PHARMA LTD.,
----------
CARBIDOPA AND LEVODOPA TABLETS, USP
DESCRIPTION
Carbidopa and Levodopa tablets, USP are a combination of carbidopa and
levodopa for
the treatment of Parkinson's disease and syndrome.
Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a
white, crystalline
compound, slightly soluble in water, with a molecular weight of 244.3.
It is designated
chemically as (—)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene)
propanoic acid
monohydrate. Its empirical formula is C
H
N
O
•H
O, and its structural formula is:
Tablet content is expressed in terms of anhydrous carbidopa which has
a molecular
weight of 226.3.
Levodopa, an aromatic amino acid, is a white, crystalline compound,
slightly soluble in
water, with a molecular weight of 197.2. It is designated chemically
as (—)-L-α-amino-β-
(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C
H
NO
, and its
structural formula is:
Carbidopa and levodopa tablets, USP are supplied in three strengths:
Carbidopa and levodopa tablets USP 10/100 mg containing 10 mg of
carbidopa and 100
mg of levodopa.
Carbidopa and levodopa tablets USP 25/100 mg containing 25 mg of
carbidopa and 100
mg of levodopa.
Carbidopa and levodopa tablets USP 25/250 mg containing 25 mg of
carbidopa and 250
mg of levodopa.
Inactive ingredients are hydroxypropyl cellulose, crospovidone,
microcrystalline
cellulose, and magnesium stearate. Carbidopa and levodopa tablets 10
mg/100 mg and
25 mg/250 mg also contain FD&C Blue 2 aluminium lake. Carbidopa and
levodopa tablets
25 mg/100 mg also contain D&C Yellow 10 aluminium lake.
10
14
2
4
2
9
11
4
FDA approved dissolution test specifications differ from USP.
CLINICAL PHARMACOLOGY
_MECHANISM OF ACTION_
Parkinson's disease is a progressive, neurodegenerative disorder of
the extrapyramidal
nervous system affecting the mobility and control of the skeletal
muscular system. Its
characteristic features include resting tremor, rigidity, and
bradykinetic movemen